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Vinorelbine has been shown to be active in hormone refractory prostate cancer.

Controversy exists regarding the proper palliative management of hormone refractory patients who have failed first line hormonal therapy

This trial intended to determine whether the addition of vinorelbine, a cytotoxic agent, provided benefit when added to second line hormone therapy.

Materials and Methods

This is a prospective randomized trial of 414 patients randomized to vinorelbine (VRL)30mg/m2, days 1 and 8 every three weeks with hydrocortisone 40mg/day +/- aminogluthimide or hydrocortisone 40mg/day +/- aminoglutethimide alone.

VRL is active and well tolerated in hormone refractory prostae cancer.

Clinical/Scientific Implications

Controversy exists regarding the utility of cytotoxic chemotherapy agents in the treatment of metastatic hormone refractory prostate cancer. The absence of data showing a survival benefit has called into question the use of a therapy with the potential for significant toxicity in this elderly population. These data support the use of vinorelbine in hormone refractory prostate cancer. Once again, no OS difference is seen. However, the patients did appear to achieve a significant palliative benefit as seen in improved pain and RFS with the addition of VRL. Little toxicity was seen. VRL may be considered another option in the management of this difficult to treat patient population.